{"publicDeviceRecordKey":"be94bc0d-c1b5-4753-bda9-d044f83c904e","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":3,"publicVersionDate":"2025-02-17T00:00:00.000Z","devicePublishDate":"2021-04-01T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"08718375867112","deviceIdType":"Package","deviceIdIssuingAgency":"GS1","containsDINumber":"08718375867129","pkgQuantity":12,"pkgDiscontinueDate":null,"pkgStatus":"In Commercial Distribution","pkgType":"Shelf box"},{"deviceId":"08718375867129","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Natus","versionModelNumber":"019-475700","catalogNumber":null,"dunsNumber":"418415568","companyName":"Technomed Engineering B.V.","deviceCount":1,"deviceDescription":"Disposable Twisted Pair Subdermal Needle Electrode, 12x0.4mm needle, 2m twisted wire, 12pairs","DMExempt":false,"premarketExempt":false,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":true,"lotBatch":true,"serialNumber":false,"manufacturingDate":false,"expirationDate":true,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":false,"MRISafetyStatus":"MR Unsafe","rx":true,"otc":false,"contacts":{"customerContact":[{"phone":"+31434086868","phoneExtension":null,"email":"info@technomed.nl"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"47714","gmdnPTName":"Subdermal needle electrode","gmdnPTDefinition":"A sterile, multi-purpose electrical conductor inserted beneath the dermal layer of a patient's skin to record/monitor electrical activity (biopotentials) for physiological measurements [typically electroencephalography (EEG), electromyography (EMG), and evoked-potential) and often to provide electrical stimulation. It typically consists of thin shaft of stainless steel connected to a lead wire that terminates with a safety connector for attachment to recording/monitoring and stimulation systems. This is a single-use device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"GXZ","productCodeName":"Electrode, Needle"},{"productCode":"IKT","productCodeName":"Electrode, Needle, Diagnostic Electromyograph"}]},"deviceSizes":{"deviceSize":[{"sizeType":"Length","size":{"unit":"Millimeter","value":"12"},"sizeText":null,"sizeString":"Length: 12 Millimeter"},{"sizeType":"Outer Diameter","size":{"unit":"Millimeter","value":"0.40"},"sizeText":null,"sizeString":"Outer Diameter: 0.40 Millimeter"}]},"environmentalConditions":{"storageHandling":[]},"sterilization":{"deviceSterile":true,"sterilizationPriorToUse":false,"methodTypes":{"sterilizationMethod":[]}},"xmlns":"http://www.fda.gov/cdrh/gudid","xsi":"http://www.w3.org/2001/XMLSchema-instance","anomaly":null,"premarketSubmissions":{"premarketSubmission":[]}}